A Study in Healthy Volunteers to Evaluate Serum and Urine Levels of the Investigational Product Versus Comparator.
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of the study is to obtain initial pharmacokinetic data in healthy patients after dosing a combination of the study medications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 19, 2006
CompletedFirst Posted
Study publicly available on registry
January 23, 2006
CompletedMarch 7, 2008
March 1, 2008
January 19, 2006
March 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Levels of study medication in blood and urine.
Secondary Outcomes (1)
Safety/tolerability
Interventions
Eligibility Criteria
You may qualify if:
- Non-smokers, BMI 18-29, no current medications
You may not qualify if:
- Significant conditions or disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deylead
Study Sites (1)
Research Site
Lenexa, Kansas, 66219, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 19, 2006
First Posted
January 23, 2006
Study Completion
December 1, 2005
Last Updated
March 7, 2008
Record last verified: 2008-03